Recall of Device Recall hypo/hyperthermia system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MEDIVANCE INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, Thermal Regulating - Product Code DWJ
  • Reason
    Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.
  • Action
    US customers were notified by telephone on 1/5-6/2005, followed by letter confirmation.


  • Model / Serial
    Catalog No. 2000-02 (115 volt) and 2000-03 (230 volt) Serial numbers 3001 thru 3080
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    AL, AZ, CO, DC, FL, GA, IA, IN, KS, MA, MD, MI, MO, NC, NY, OH, PA, TX, VA, WA. No government or military distribution. Foreign distribution to Austria, Belgium, Canada, Germany, Japan, Netherlands, Norway, Scotland.
  • Product Description
    Arctic Sun Temperature Management System
  • Manufacturer


  • Manufacturer Address
    MEDIVANCE INC., 1172 W Century Dr Ste 240, Louisville CO 80027-1681
  • Source